Recon: FDA approves Cytokinetics’ heart drug in first for drugmaker; Shionogi forges $2.5 billion buyout of Tanabe Pharma’s ALS therapy Radicava
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 3 key issues to watch at FDA as Makary struggles to stabilize the agency (STAT)
- Trump, nine pharmaceutical companies strike deal to cut prices (Reuters)
- Recalls: They Aren’t Over ‘Til FDA Says So, But Who Knows When That Will Be (FDA Law Blog)
- Ipsen adds to deal spree with ADC from Shanghai biotech Simcere Zaiming (Endpoints)
- Nine more MFN deals; Western drugmakers turn to China; Chai Discovery's raise; and more (Endpoints)
- Sputnik developer becomes head of Russia's top vaccine centre (Reuters)
- Roche CEO points to higher future drug prices in Switzerland after US deal (Reuters)
- EU proposal would simplify Medical Device Regulation (MedTech Dive)
- Finally A Happy New Year In Switzerland? (MedTech Insight)
- A seasoned biotech VC looks to 2026 and sees a wave of IPOs coming (STAT)
- ALS med Radicava to change hands as Shionogi inks $2.5B buyout (Fierce Pharma)
- Cytokinetics heart drug wins FDA approval, the biotech’s first (STAT)
- What Ozempic might tell us about the future of Alzheimer’s (STAT)
- Researchers have a moral obligation to push back when their studies are twisted to promote false health claims (STAT)
- Aktis Oncology files for IPO to fund Lilly-partnered radiopharma pipeline (Endpoints)
- AstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer (Endpoints)
- Boehringer taps Rectify to create pills for chronic kidney disease (Endpoints)
- AstraZeneca's ceralasertib-Imfinzi drug combo misses survival target in lung cancer trial (Reuters)
- Samsung Biologics to buy US drug production facility from GSK for $280 million (Reuters)
- Medtronic’s diabetes spinoff MiniMed files for IPO (MedTech Dive)
- Abbott receives FDA approval for Volt PFA system (MedTech Dive)
- GlucoModicum’s Needle-Free Sofio Could Offer Alternative CGM Approach (MedTech Insight)
- HHS Targets Chest Binder Vendors in New Regulatory Crackdown (MedTech Insight)
- Philips To Acquire SpectraWAVE To Expand Intravascular Imaging Portfolio (MedTech Insight)
- Study revives debate about unpopular diet for cancer patients (STAT)
- American food safety could be headed for a breakdown (STAT)
- UnitedHealthcare delays controversial RPM policy change (STAT)
- Mass General Brigham bolstered its bottom line. Other Mass. hospital groups reported multimillion losses (STAT)
- Hedge funds short healthcare providers as subsidies debate intensifies (Reuters)
- HHS seeks input on speeding AI adoption in clinical care (MedTech Dive)
- NIH study was a beacon for the topical steroid withdrawal community. Then, amid federal upheaval, the research stalled (STAT)
- Francis Collins: ‘I think of science as glimpsing God’s mind’ (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
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